Lead QA Manager - Process and Cleaning Validation
Key Responsibilities:
* Defines the Process Validation strategy in conjunction with Manufacturing Science and Technology (MSAT).
* Serves as a Quality and Compliance representative on cross-functional technical project teams.
* Develops the Cleaning Validation strategy and process-specific cleaning validation activities in conjunction with MSAT.
* Covers Quality and Compliance objectives during different project phases for Process and Cleaning Validation activities.
* Supports and approves Quality Risk Analysis related to manufacturing processes and equipment cleaning.
* Reviews and approves Process and Cleaning Validation-related documents, such as plans, protocols, and reports.
* Reviews and approves periodic reports related to the process and cleaning lifecycle.
* Ensures data accuracy within process and cleaning validation reports.
* Supports specific projects in the process and cleaning validation area of expertise to enhance quality standards.
* Reviews and approves Process and Cleaning Validation-related Deviation, OOS Investigations, Change Requests, and CAPAs.
* Supports internal, stakeholder, and regulatory audits and inspections.
Requirements:
* Bachelor's, Master's, or Doctoral degree in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering, or related field.
* At least 5 years of experience in biopharmaceutical manufacturing, preferably in QA/qualification/validation/MSAT roles, with a strong background in cGMPs.
* Excellent communication skills and ability to interact with various stakeholders, including customers and regulatory agencies.
* Fluency in English; proficiency in German is an advantage.
Lonza operates at the intersection of science and business. Our goal is to create value by improving lives through innovative products and services.
We offer a dynamic work environment that encourages collaboration, creativity, and continuous learning. Join our team to contribute your skills and experience to the development of life-changing solutions.